Electro-cautery, also referred to simply as “cautery” or “electric cautery” is commonly used in the surgical operating room (OR), and other medical/surgical procedure sites, for a wide variety of applications, including cutting through tissue with minimal bleeding and hemostasis or the termination of bleeding. It is used during a wide range of medical/surgical procedures, from brain surgery and eye surgery, to open heart and colorectal surgery. Electro-cautery is typically delivered in the unipolar or bipolar mode. It is often used in patients who already have an implantable therapeutic devices or monitoring devices that operate electrically, such as cardiac pacemakers, implantable cardiac defibrillators (ICD), neurological stimulators, gastric stimulators, electrocardiographic [ECG] monitors, physiologic sensor systems and similar devices. Cautery is also used during the implantation for other medical/surgical procedures in patients who already have implantable devices (e.g., pacemakers, ICDs) in place. At present, there is concern that use of cautery, especially unipolar cautery, has the potential to interfere with normal implantable pacemaker and implantable cardioverter defibrillator (ICD) function. Specifically, there are concerns that the pacemaker may sense the electrical ‘noise’ (i.e., electrical signals) generated by the cautery device and this sensing of these extraneously generated electrical signals will either inhibit pacemaker/ICD function or potentially cause a change in pacemaker/ICD programming, or damage implantable device circuitry.
At the present time, conventional medical/surgical practice is such that during surgery of any form (whether placement of the implantable therapeutic device itself, or concomitant surgery in an individual who has an implantable device that was placed previously), there is the potential for electrical interference with an implantable pacemaker or defibrillator and the concern is further heightened if the cautery is performed within 6 inches of the implantable device. As such, it is recommended by many manufacturers and medical specialty organizations that write clinical guidelines that patients with pacemakers or ICDs undergo device reprogramming prior to surgery to preclude the implantable device from detecting the external electrical signal and thereby avoid altering implantable device function. Such pre-surgical intentional reprogramming may include disabling therapeutic or sensing functions of the implanted pacemaker or ICD device, leaving the patient temporarily without the defibrillation or pacing benefits of the implanted device. Furthermore, given the recommendation to pre-operatively reprogram devices to a non-sensing mode, additional recommendations are given by implantable device manufacturers and medical specialty organizations that write clinical guidelines that these implanted therapeutic or monitoring devices need to be re-assessed after surgery, at which time they are reprogrammed back to the pre-surgical normal function. These programming and re-programming steps require considerable human resources, and may be inconvenient in emergency situations as well as during procedures in which manufacturer representatives or specialized implantable device professionals are not typically present.